[00:00:00] Speaker 00:
We'll hear argument next in number 20-1055, N. Ray Sabin, Mr. Vodopia.

[00:00:09] Speaker 01:
Thank you.

[00:00:12] Speaker 01:
In his opening briefs, in his opening reply briefs before the board appellant, Robert Sabin, presented two arguments.

[00:00:20] Speaker 01:
The first is that the board fails to properly consider the claims to include certain limitations in the preamble and body.

[00:00:30] Speaker 01:
which distinguish both the primary 103 reference saving 082 and the secondary reference to fray.

[00:00:41] Speaker 01:
The second argument is that appellant indeed overcomes the presumption of obviousness under the holding of Peterson as the board ignored the evidence that phrase range is so broad that it does not invite routine optimization.

[00:00:58] Speaker 01:
if you recall, that broad was 7 by 10 to the minus 4 grams to 7 grams per day for a 70 kilogram person.

[00:01:08] Speaker 01:
Appellant first argued that the board failed to properly construe claim 6 to include the limitations in the preamble and body.

[00:01:16] Speaker 01:
And those limitations, the missing limitation in the preamble and in the body is to effectively treat Alzheimer's disease and related amyloid plaque development and reduction of amyloid plaque

[00:01:26] Speaker 01:
protein aggregation and amyloid doses, and had the board considered and construed the claims properly, these two limitations would have, in the preamble and in the body, would have distinguished they've been 08-2 and for a separately and in combination.

[00:01:46] Speaker 01:
And so the examiner first and then the board after failed to consider the missing limitations when it construed the claims, and this is fatal error because all the words in the claims

[00:01:56] Speaker 01:
are important, as suggested by Amgen.

[00:02:00] Speaker 02:
This is Judge Toronto.

[00:02:03] Speaker 02:
Why isn't there a very large forfeiture problem?

[00:02:10] Speaker 02:
I mean, when you say the examiner and then the board failed to do something, it's a little awkward to say they failed to do something that they were not asked to do.

[00:02:19] Speaker 02:
And am I remembering right?

[00:02:23] Speaker 02:
You did not.

[00:02:25] Speaker 01:
In a sense, Judge.

[00:02:27] Speaker 02:
A claim construction position that said the various words after the and after Alzheimer's disease required something more.

[00:02:37] Speaker 01:
Well, in appellant's brief before the board, the appellant presented all of the claims, including those limitations, the first office action issued

[00:02:50] Speaker 01:
And the examiner proposed a prima facie case of obviousness where he presented those claims and didn't argue the limitations.

[00:02:59] Speaker 01:
And I think it started from there.

[00:03:03] Speaker 01:
What occurred though is that in the reply brief before the board, Appellant did raise the issue.

[00:03:12] Speaker 01:
The board's September 12, 2019 decision did not address the fact that Appellant in

[00:03:20] Speaker 01:
in his reply brief raised the issue, uh, where 44.4, 37 CFR, 44.41 B2 sets out that a new argument can be replaced and can be raised in a reply brief for good cause.

[00:03:37] Speaker 01:
And a proper construction of these claims we believe is good cause.

[00:03:44] Speaker 01:
Um, the, the, the, the board should have remanded the case back down to the examiner.

[00:03:49] Speaker 01:
These limitations were significant.

[00:03:51] Speaker 01:
They're the heart of the case.

[00:03:52] Speaker 01:
They come from the ARGON studies.

[00:03:55] Speaker 01:
The ARGON studies verified that this treatment in the claimed range is efficacious.

[00:04:03] Speaker 04:
Counsel, this is Judge Moore.

[00:04:05] Speaker 04:
If I understand your argument, it was you can always raise a new argument in your reply brief for the first time for good cause.

[00:04:14] Speaker 04:
And your only explanation of why this is good cause is claim construction is always good cause because it's important to construe the claims properly.

[00:04:22] Speaker 04:
If I'm understanding that argument, you're saying as a matter of law across the board, claim construction can always be erased for the first time in reply brief and the board is forced to address it.

[00:04:33] Speaker 01:
No, Your Honor.

[00:04:35] Speaker 01:
I'm not going that far as to make that presumption.

[00:04:41] Speaker 01:
What occurred is that

[00:04:43] Speaker 01:
In the exam, sorry, exactly, yes.

[00:04:47] Speaker 01:
In the examiner's reply brief, the issue was raised.

[00:05:00] Speaker 01:
Let's see.

[00:05:12] Speaker 01:
I believe it was page 24 of the examiner's brief.

[00:05:26] Speaker 01:
At APPX 11, the board stated, sorry, the examiner stated that at most, appellate evidence elucidates the mechanisms by which phytic acid may be effective in alleviating symptoms of Alzheimer's disease

[00:05:40] Speaker 01:
By providing protection against APPC-99 mediated toxicity, enhancing cytochrome oxidase, which is mitochondrial function, goes to mitochondrial function, or suppressing malindialdehyde or lipid peroxidation.

[00:05:59] Speaker 01:
The results of the treatment, of the claimed treatment, realizes these effects.

[00:06:09] Speaker 01:
And they were, again, brought up by the examiner in his response to the appellant's opening brief before the board.

[00:06:22] Speaker 01:
And I believe it suggests that this is an issue before the board.

[00:06:30] Speaker 01:
And then, again, in the reply brief before the board, appellant raised the issue directly.

[00:06:39] Speaker 01:
I'm not suggesting that one can avoid raising an argument in their brief and then raise it in the reply brief without good cause, but what I'm suggesting is that this is indeed a good cause because these limitations come from the studies and there's just no way that these claims can be properly construed and then an obviousness analysis conducted

[00:07:08] Speaker 01:
unless they include these limitations.

[00:07:10] Speaker 04:
Council, time is short.

[00:07:12] Speaker 04:
And why don't we just suppose we accept your argument that these are not waived.

[00:07:18] Speaker 04:
Why don't you tell us why you think these preamble terms are limiting?

[00:07:21] Speaker 04:
You referenced in-rate fought, which I remember.

[00:07:26] Speaker 04:
And in that case, there was actually antecedent basis in the claim body for the limitation, the preamble.

[00:07:34] Speaker 04:
I mean, antecedent basis, it referred back to the preamble.

[00:07:38] Speaker 04:
for antecedent basis.

[00:07:39] Speaker 04:
And so that is a significant difference, I think, between that set of facts and this set of facts.

[00:07:46] Speaker 04:
So what is your best argument for why we ought to interpret this preamble language as not a statement of intended use, but rather an actual structural limitation?

[00:07:58] Speaker 01:
Because the body of the claim refers back to it.

[00:08:01] Speaker 01:
Where?

[00:08:01] Speaker 01:
At the end of Claim 6, it says, big administrative amount of point

[00:08:07] Speaker 01:
of 0.5 grams to about 18.75 grams per day to effectively treat Alzheimer's disease and related amyloid plaque development and reduction of amyloid plaque protein aggregation of amyloid doses.

[00:08:20] Speaker 01:
So the clause is repeated in the body of the claim preceding, preceded by the phrase to effectively treat and it's articulated in the preamble before the consisting essentially of.

[00:08:35] Speaker 01:
So I believe it is tied to the preamble.

[00:08:37] Speaker 01:
The body of the claim is tied to the preamble.

[00:08:39] Speaker 04:
So I think that we... Well, Counsel, if you think the limitation is repeated in that portion of the body of the claim about effectively treat Alzheimer's disease, why do you need the preamble?

[00:08:53] Speaker 04:
Well, you know, it's not quite repeat... I mean, the question is... Yeah, it isn't quite repeated, and it doesn't actually use antecedent basis.

[00:09:00] Speaker 04:
Antecedent basis is a very specific

[00:09:02] Speaker 04:
patent prosecution concept, where you refer back by saying the as opposed to and, you know, it's very precise in patent jargon.

[00:09:12] Speaker 04:
This isn't antecedent basis.

[00:09:15] Speaker 04:
If anything, it's restating it in a slightly different way, which would therefore imply the preamble is not in fact a limitation.

[00:09:24] Speaker 01:
I see that it's tied back.

[00:09:25] Speaker 01:
I mean, it says

[00:09:26] Speaker 01:
0.5 grams to about 1875 grams per day to effectively treat Alzheimer's disease, dot, dot, dot.

[00:09:34] Speaker 04:
No, it doesn't have a dot, dot, dot, but okay, go ahead.

[00:09:36] Speaker 01:
Sorry.

[00:09:38] Speaker 01:
To effectively treat Alzheimer's disease and related amyloid plaque development and reduction of amyloid plaque, protein aggregation and amyloid development.

[00:09:44] Speaker 04:
So why isn't that by itself the full portion of the structure of the claim?

[00:09:51] Speaker 04:
What about that makes you think it is referring back for antecedent basis, which is a technically precise concept to the preamble?

[00:10:02] Speaker 01:
Because it's introduced in the preamble, then it's tied together with the two-effectively treat.

[00:10:10] Speaker 04:
But why isn't the two-effectively treat complete in its own structure?

[00:10:16] Speaker 04:
Why do you have to look back at the preamble?

[00:10:18] Speaker 01:
It may be, Judge.

[00:10:21] Speaker 01:
I was responding to the solicitor's position.

[00:10:26] Speaker 01:
I believe that the claim clearly requires construction to include the expression to effectively treat Alzheimer's disease and related amyloid plaque development and reduction of amyloid plaque protein aggregation and amyloid doses.

[00:10:43] Speaker 01:
I mean, that was our point, Judge.

[00:10:45] Speaker 01:
I'm not sure if I'm being clear here.

[00:10:52] Speaker 00:
OK, anything further, Mr. Rodelpia?

[00:10:56] Speaker 00:
Anything further?

[00:10:57] Speaker 00:
Yes.

[00:10:59] Speaker 01:
The second appellant second ordinance.

[00:11:01] Speaker 00:
You're into your rebuttal time.

[00:11:04] Speaker 01:
Oh, I wonder, can I have some of that time back?

[00:11:12] Speaker 00:
You can use it all now, if you wish.

[00:11:15] Speaker 00:
No, the time in the first 10 minutes.

[00:11:20] Speaker 01:
We got sort of sidetracked with that.

[00:11:22] Speaker 01:
that limitation, and I was hoping to present that second argument.

[00:11:27] Speaker 01:
Okay, let me get into it.

[00:11:28] Speaker 01:
Essentially, in our understanding, there's no reason that the skilled artisan would have looked to fray to modify what's taught by Sabin 082, the primary reference.

[00:11:48] Speaker 01:
We don't see that GRACE treated, invented a method of treating Alzheimer's disease.

[00:11:53] Speaker 01:
Looking at GRACE paragraph five, which is the appendix page 108084, GRACE says that the invention, sorry, four and five, the invention provides a message for enhancing cellular function protection of tissue components.

[00:12:14] Speaker 01:
where five says, the invention provides a method protecting muscarinic acetylcholine receptors and increasing the efficacy of an agent that directly or indirectly affects an MACHR.

[00:12:26] Speaker 01:
Essentially, he mentions in several of the paragraphs Alzheimer's disease as an afterthought.

[00:12:36] Speaker 01:
I mean, he articulates in paragraph 12

[00:12:40] Speaker 01:
First, that the method of, again, of treating muscarinic acetylcholine receptors can treat or prevent, in paragraph 12, that it can treat or prevent a CNS disorder.

[00:12:56] Speaker 01:
But it goes into all these diseases that are just, about 90% of all the diseases known to man, Alzheimer's disease, Parkinson's disease, Lewy body dementia, multiple sclerosis,

[00:13:08] Speaker 01:
Um, tumors in the brain, spinal cord, prion diseases, spinal cord injuries.

[00:13:13] Speaker 01:
I mean, and then paragraph 13 goes into blood diseases, neuropathies.

[00:13:18] Speaker 01:
Um, he just goes on and on.

[00:13:21] Speaker 01:
And the, and so we don't believe that he really, that there's any really written description support for treating Alzheimer's disease, even though Appellant's initial and reply brief articulated it

[00:13:36] Speaker 01:
in terms of enablement under 112A.

[00:13:39] Speaker 01:
There doesn't appear to be any support at all for treating Alzheimer's disease.

[00:13:44] Speaker 01:
He goes through four examples to show, he goes through four examples beginning on page 8Px1062, and all of them are just hypothetical.

[00:14:01] Speaker 01:
The examples talk about

[00:14:05] Speaker 01:
the ability in the art to verify the efficacy of his invention of treating NACHRs.

[00:14:14] Speaker 01:
But his examples show no results.

[00:14:17] Speaker 01:
They do not even verify the treatment of NACHRs, let alone provide any kind of data to try to tie successful treatment of NACHRs

[00:14:32] Speaker 01:
to any kind of CNS disorder, let alone Alzheimer's disease.

[00:14:36] Speaker 01:
There's nothing in prey to indicate that MACHRs somehow affect Alzheimer's disease.

[00:14:46] Speaker 01:
The best he had was example one, which is paragraph 109, again, of APTX 1094.

[00:14:54] Speaker 01:
And what that articulates is that pyrophosphate protects the MACHR, pyrophosphate, not

[00:15:00] Speaker 01:
not the inventive inositol hexaphosphate, which has got six phosphates.

[00:15:06] Speaker 01:
Pyrophosphate protects the MSAs from the inactivation of the LMW inhibitor or by the combination of hemi and peroxide.

[00:15:15] Speaker 01:
And that's in figures one.

[00:15:17] Speaker 01:
You know, it's just nothing to tie, for example, the results shown in figure one with pyrophosphate to inositol hexaphosphate affecting Alzheimer's disease.

[00:15:30] Speaker 01:
or amyloid precursor protein, et cetera.

[00:15:33] Speaker 01:
And that's pretty much our argument.

[00:15:36] Speaker 01:
We don't see that FREI truly invented it.

[00:15:39] Speaker 01:
And so I just want to end with the fact that FREI, this was a pending application, FREI, and FREI issued a patent.

[00:15:51] Speaker 01:
Excuse me, I have about 10 seconds.

[00:15:53] Speaker 00:
Mr. Vadoppia, we're out of time.

[00:15:56] Speaker 00:
We'll give you, we'll restore one minute of your rebuttal.

[00:16:00] Speaker 01:
Okay, and I will save it to Ben.

[00:16:02] Speaker 00:
Thank you.

[00:16:04] Speaker 00:
Okay.

[00:16:05] Speaker 00:
Thank you.

[00:16:05] Speaker 00:
We'll hear from Ms.

[00:16:06] Speaker 00:
Kweller.

[00:16:08] Speaker 03:
Thank you, Your Honors, and may it please the court.

[00:16:10] Speaker 03:
Substantial evidence supports the obviousness of the claimed method over the prior art of Sabin and Frey.

[00:16:17] Speaker 03:
Appellant was already granted a patent, the Sabin patent, an almost identical method step, which was the oral administration of phytic acid to Alzheimer's disease patients.

[00:16:28] Speaker 03:
So the board correctly found

[00:16:30] Speaker 03:
that any difference in dose between what was disclosed in Sabin and the claims that issued here was rendered obvious by phrase disclosure of doses that overlapped the claimed range for phytic acid and the treatment of Alzheimer's disease.

[00:16:47] Speaker 03:
And appellants failed to overcome the presumption of obvious created by this overlap by showing of either teaching away or unexpected results.

[00:16:56] Speaker 03:
I'll briefly address

[00:16:58] Speaker 03:
the discussion this morning regarding the amyloid plaque limitation.

[00:17:03] Speaker 03:
As DOJ Toronto pointed out, there is a significant forfeiture issue here.

[00:17:10] Speaker 03:
As the appellant admitted, they raised this for the first time in their reply brief to the board, which under 37 CFR 41.41 is just simply too late.

[00:17:22] Speaker 03:
Council, this is Jess Moore.

[00:17:24] Speaker 04:
Can I ask a question as point of clarification?

[00:17:27] Speaker 04:
Am I right in remembering that they never raised the amyloid plaque issue in the body of the claim that the only thing they did in the reply brief would point to the preamble?

[00:17:40] Speaker 03:
Let me look exactly.

[00:17:42] Speaker 03:
They say,

[00:17:44] Speaker 03:
The answer does not account for each required claim limitation.

[00:17:49] Speaker 03:
And then they just quote the two effectively treat.

[00:17:55] Speaker 03:
So that is the body of the claim limitation, I believe, not the preamble.

[00:18:00] Speaker 03:
So they just, in their reply brief, refer to the body of the claim, not the preamble.

[00:18:05] Speaker 03:
And that's at Appendix 826 moving over to 827.

[00:18:09] Speaker 03:
It spans those two pages.

[00:18:11] Speaker 03:
So they did refer to the body of the claim, but that was the very first time that they mentioned this claim limitation in this one kind of sentence spanning two pages of the reply brief.

[00:18:24] Speaker 03:
There was nothing in the examiner's answer that was new.

[00:18:28] Speaker 03:
The examiner's answer was almost completely identical to the final rejection in this case, so there was nothing in the examiner's answer that provided good cause under 41.41

[00:18:40] Speaker 03:
to allow them to raise this issue at this point.

[00:18:44] Speaker 03:
So the board properly did not consider it.

[00:18:47] Speaker 03:
And at that point, it is waived.

[00:18:48] Speaker 03:
And they never filed a request for re-hearing, saying the board misapprehended or overlooked anything.

[00:18:54] Speaker 03:
And I disagree with one of the statements by Appellant's Council that this is the heart of the case.

[00:19:00] Speaker 03:
You would think if it was the heart of the case, their appeal brief would have mentioned it.

[00:19:05] Speaker 03:
Instead, as we pointed out in the director's brief

[00:19:08] Speaker 03:
Page 28, we took out a number of statements from their appeal brief, which only focused on treating Alzheimer's disease.

[00:19:17] Speaker 03:
No mention of these amyloid plaque limitations.

[00:19:21] Speaker 03:
And even if you go back in prosecution, for example, I think a good example to look at is appendix 614 to 617.

[00:19:29] Speaker 03:
This is the response essentially right before the final rejection.

[00:19:35] Speaker 03:
And just over and over and over again throughout this, they only talk about Alzheimer's disease.

[00:19:42] Speaker 03:
For example, if you look at page 615, appendix 615, they talk about applicant's invention is a standalone monotherapy for Alzheimer's disease.

[00:19:54] Speaker 03:
No mention of amyloid plaque.

[00:19:56] Speaker 03:
So I disagree with Appellant's characterization of this amyloid plaque limitation as the heart of the case.

[00:20:02] Speaker 02:
This is Judge Toronto.

[00:20:05] Speaker 02:
Can I ask a question that relates to your second and third arguments about this plaque limitation?

[00:20:17] Speaker 02:
So put aside for the moment the question of forfeiture.

[00:20:21] Speaker 02:
You say that the body language to effectively treat

[00:20:30] Speaker 02:
Alzheimer's and to do these other things is a statement of intended use.

[00:20:38] Speaker 02:
Have we really said that a limitation in a claim that uses the language to effectively treat something and I guess it would also

[00:20:55] Speaker 02:
follow on and to effectively, yeah, to effectively treat the disease and the related plaque development, that that is a non-limiting statement of intended use because of the word two.

[00:21:12] Speaker 03:
I believe the closest cases would be the Bristol Myers case and the Kapaxon case.

[00:21:22] Speaker 03:
I think I'll start with the Kapaxon case.

[00:21:24] Speaker 03:
In that case, the body of the limitation

[00:21:29] Speaker 03:
said, so to thereby treat the human patient, and then it continued on with a dose that they were going to give.

[00:21:37] Speaker 03:
And this court found that that claim language did not have any bearing on the method being practiced.

[00:21:44] Speaker 03:
It did not change the steps.

[00:21:46] Speaker 03:
And the inmate to Pakistan followed the Bristol Myers case, which came to a similar conclusion, again, with respect to the human patient.

[00:21:56] Speaker 02:
I'm sorry.

[00:21:56] Speaker 02:
I'm not remembering.

[00:21:58] Speaker 02:
Copaxon or Bristol Myers for that matter, so that we ruled there that it was actually immaterial to, if it were infringement or to prior art, whether there was actually an effective treating going on?

[00:22:20] Speaker 03:
That's the understanding of those cases, yes.

[00:22:22] Speaker 03:
And I think the reason being is that

[00:22:26] Speaker 03:
there was no change in the dosing based on that limitation.

[00:22:30] Speaker 03:
So the claim itself had a dose, as this claim does, had a dose already.

[00:22:37] Speaker 03:
What you were going to effectively treat did not change the dosing recited by the claim.

[00:22:44] Speaker 03:
And so it really was just

[00:22:46] Speaker 03:
an extra statement of intended use or intended results for the claim that did not change any of the manipulative steps and did not really make a difference in any of the method steps of the claim in both those cases as similar to this case.

[00:23:04] Speaker 03:
And so I think those are the two that are closest here.

[00:23:08] Speaker 03:
And as Your Honor Desmoore pointed out in my thought, we've distinguished that in our brief.

[00:23:14] Speaker 03:
In addition to the antecedent basis issue, the travel trailer language in that case was also deemed limiting because it added structural requirements, it adding a living area requirement and a towability requirement that was a structural difference, not just the statement of intended results

[00:23:32] Speaker 03:
Here, the amyloid plaque limitations are just statements of what they hope to achieve or what they'd like to achieve with the administration, not changing any of the steps of the method.

[00:23:43] Speaker 04:
But, Council, Council, this is Judge Moore.

[00:23:45] Speaker 04:
Following up on this line of questioning, why isn't the to effectively treat Alzheimer's disease or to effectively treat amyloid plaque development relevant to the amount that you would actually administer?

[00:23:58] Speaker 04:
This is a large range, .5 to 18.75 grams.

[00:24:03] Speaker 04:
So why isn't that subsequent limitation effective as to the amount within that range that you would need to use for any given patient?

[00:24:14] Speaker 03:
I think that's an excellent question, Your Honor.

[00:24:17] Speaker 03:
We presented in our brief that we did believe this was a statement of intended results.

[00:24:20] Speaker 03:
However, this may be one reason why if the court does not find this issue waived, there are some factual questions that should be addressed and therefore it would be most prudent to remand.

[00:24:34] Speaker 03:
To the board, we put these this briefing in our brief just for completeness sake.

[00:24:43] Speaker 03:
But because it was waived and the board never addressed and the examiner never addressed it.

[00:24:49] Speaker 03:
We do believe it is most prudent if this court does not believe it was waived.

[00:24:54] Speaker 03:
to remand it for those sort of factual considerations and arguments to be raised and addressed by either the examiner or the board.

[00:25:02] Speaker 04:
One problem that I have with the waiver argument is the board didn't find it waived.

[00:25:06] Speaker 04:
It just failed to address it.

[00:25:10] Speaker 03:
Well, Your Honor, I believe the board's rules provide that they do not have to consider an argument that was not raised.

[00:25:17] Speaker 03:
So 4141 does provide the board's

[00:25:22] Speaker 03:
you know, guidance on that which a appellant should have been aware of.

[00:25:26] Speaker 03:
And furthermore, I think also the fact that it was just one sentence spanning two pages at the very bottom stuck in after years of prosecution where there was just never raised.

[00:25:39] Speaker 03:
I also would say that that was not sufficient really to put the board on notice.

[00:25:44] Speaker 03:
that this was an issue, that they were supposed to address it.

[00:25:47] Speaker 03:
You know, the skeletal one-sentence argument really did not adequately put the board on notice of this argument that they were supposed to address.

[00:25:56] Speaker 03:
So it's understandable that the board responded to all the other arguments that they made in their appeal briefing and through the course of prosecution.

[00:26:05] Speaker 04:
And with respect to the fact, I believe, of Helen's... When you say this one sentence wasn't sufficient to put them on notice,

[00:26:13] Speaker 04:
they actually added emphasis on page 827, and they said the examiner's answer failed to identify either where Sabin or Fray teach, and then they have the limitation, and they added emphasis to the and, which I think is a pretty clear signal that this is not just about Alzheimer's, that it avoids amyloid plaque reduction as well.

[00:26:37] Speaker 04:
How much more do you think they would have had to say

[00:26:43] Speaker 04:
for that not to be.

[00:26:45] Speaker 04:
You say it's skeletally raised.

[00:26:47] Speaker 04:
So how much more would they have had to say?

[00:26:50] Speaker 03:
I think one of the things they should have done is raise it in their appeal brief.

[00:26:54] Speaker 03:
So I think that is our main argument is that their appeal brief over and over and over again.

[00:27:01] Speaker 04:
And isn't it correct that the board could find something not raised in the initial appeal brief

[00:27:08] Speaker 04:
waived and therefore not address it if it's only raised in reply for the first time.

[00:27:14] Speaker 03:
That's correct, Your Honor.

[00:27:16] Speaker 04:
But my problem is now I'm kind of circling back to what my problem was.

[00:27:19] Speaker 04:
The board didn't do that.

[00:27:21] Speaker 04:
So my problem is the board didn't conclude that it was waived.

[00:27:25] Speaker 04:
You're absolutely right that the board had the authority to conclude it was waived and may have done so and maybe we would have reviewed that finding.

[00:27:34] Speaker 04:
But the board didn't find it waived.

[00:27:36] Speaker 04:
They just didn't address it.

[00:27:37] Speaker 04:
And under the APA, doesn't the board have an obligation to address all of the arguments that are raised?

[00:27:45] Speaker 03:
Stepping back to your first point, I don't believe a party's waiver to this court depends on whether the board

[00:27:53] Speaker 03:
find something waived in the reply brief.

[00:27:55] Speaker 03:
I don't know of any cases that have found that to be the case.

[00:28:02] Speaker 04:
Do you know of any cases where we have found an argument was waived because it was only raised in the reply brief even though the board failed to address it at all?

[00:28:11] Speaker 03:
No, I am not aware of one.

[00:28:13] Speaker 03:
I was not able to find one there.

[00:28:15] Speaker 03:
There are plenty of cases that affirm the board's finding of waiver.

[00:28:19] Speaker 03:
Right.

[00:28:20] Speaker 04:
No, absolutely.

[00:28:22] Speaker 04:
And the APA requires the board to address every argument that's made.

[00:28:25] Speaker 04:
And so here we have an argument made about a claim limitation.

[00:28:29] Speaker 04:
Just drop the whole preamble thing because that to me was just noise.

[00:28:34] Speaker 04:
But we have an argument made about a particular claim limitation not being disclosed by the references.

[00:28:40] Speaker 04:
And we have the failure of the board to address it at all.

[00:28:43] Speaker 04:
Not only did they not address it on the merits, they didn't conclude it was waived.

[00:28:47] Speaker 04:
I don't know how that satisfies the APA, which requires the board to address with particularity all of the arguments made.

[00:28:55] Speaker 03:
Well, I believe underlying the APA is that it's required to raise all the arguments properly raised, and I would argue that under 37 CFR 4141 and 37 CFR 4137, which also talks about the fact that arguments not included in the appeal brief will be refused consideration by the board.

[00:29:15] Speaker 03:
Both those two provide that this argument was not properly raised, and the board

[00:29:20] Speaker 03:
with respect to a different issue regarding what claim was representative, but they did talk and cite 4137.

[00:29:27] Speaker 04:
Does the board have the discretion?

[00:29:31] Speaker 04:
I mean, we certainly have the discretion, right?

[00:29:34] Speaker 04:
Our court has the discretion to address an issue raised in a reply brief for a first time.

[00:29:38] Speaker 04:
We usually don't do so, but we have the discretion to do so.

[00:29:41] Speaker 04:
Does the board similarly have discretion to consider arguments raised for the first time in the reply brief or is the rule absolute that they do not have the discretion?

[00:29:51] Speaker 03:
So under the rule, appellants can come forward with good cause and that the board can look at that and decide whether or not there is good cause and use its discretion to look at the argument.

[00:30:01] Speaker 03:
Appellants did not do so here.

[00:30:03] Speaker 03:
The first time that they mentioned good cause is in the reply brief to this court, which is just simply too late.

[00:30:11] Speaker 03:
So yes, the board does have discretion, but it's at appellants urging that there is good cause and no such position was stated here.

[00:30:23] Speaker 03:
I'd like to, just with my last 40 seconds, just address the facts, appellant's argument about the range not being too broad.

[00:30:31] Speaker 03:
Again, appellant, as with all of its proving to the board and to this court, is really isolatingly talking about fray alone and failing to consider the entire teachings of Sabin, which already tells you the dose, the type of administration, and the patient to give it to.

[00:30:48] Speaker 03:
Frey was directed to Alzheimer's disease.

[00:30:51] Speaker 03:
There was a discussion about Frey never talking about Alzheimer's disease.

[00:30:55] Speaker 03:
I'd just like to point the court to Appendix 1088, paragraph 56 where Alzheimer's disease is identified as the preferred treatment for this Frey publication.

[00:31:06] Speaker 03:
So if there's no more questions, I'd ask the court to affirm the board.

[00:31:10] Speaker 00:
Thank you.

[00:31:16] Speaker 00:
Mr. Vadoffia, you have a minute.

[00:31:19] Speaker 01:
Yes.

[00:31:20] Speaker 01:
You know, I just want to point out that the CREI reference issued as a patent with two claims.

[00:31:27] Speaker 01:
The first is a method of treating muscarinic receptors in a subject having a CNS infection comprising meningitis by delivering an effective amount of pamidronate, which is a calcium uptake drug for use in cancer patients.

[00:31:46] Speaker 01:
By bypassing the blood-brain barrier, by intranasally administering the upper one-third of the subject's nasal cavity, the effective amount of chamondranate or pharmaceutically-acceptableable salt thereof.

[00:32:00] Speaker 01:
So treating the subject's muscarinic receptors that are affected, there is... What Trey did was it

[00:32:16] Speaker 01:
Mr. Fray rethought his initial disclosure during the prosecution of this case, and in March 7, 2010, modified the claims and made clear that systemic administration of the entire range of Fray, that is 7 milligrams to 7 grams, is problematic.

[00:32:39] Speaker 01:
And so he said, lower that dose and put it through the nose.

[00:32:43] Speaker 01:
Our position is that looking from Sabin 082, the skilled person would not have looked from Sabin 082 to Fray because Fray has pretty much articulated that nasal administration is the way to go.

[00:33:03] Speaker 01:
The systemic administration, oral administration is problematic.

[00:33:07] Speaker 01:
And there's no way that Sabin, which Sabin-082, which recommends 35 grams per day to 210 grams per day, would have looked to Frey to nasally administer a composition.

[00:33:24] Speaker 00:
How could you do it like that?

[00:33:26] Speaker 00:
I think we're well over your time.

[00:33:29] Speaker 00:
Thank you very much.

[00:33:30] Speaker 00:
I hope my colleagues have further questions.

[00:33:33] Speaker 00:
Thank both of you.

[00:33:35] Speaker 00:
And the case is submitted.

[00:33:38] Speaker 00:
But thank you all.

[00:33:41] Speaker 02:
The honorable court is adjourned until tomorrow morning at 10 a.m.